Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Neoplasms, Carcinoma, Non-small Cell Lung
Trial Information
Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologically documented non-small cell lung cancer with metastases (Stage IV or
recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
- At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for
localized disease does not count as a prior therapy for metastatic disease).
Exclusion Criteria:
- Central lung lesions involving major blood vessels (arteries or veins). (Central
lesions that maintain the structural integrity of vessels have the potential to bleed
if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
case where there is any question as to whether blood vessels are involved.)
- Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients
with a history of Grade 1 hemoptysis within 30 days of entry are not eligible
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Objective Response (OR)
Outcome Description:
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome Time Frame:
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4061011
NCT ID:
NCT00094094
Start Date:
February 2005
Completion Date:
July 2007
Related Keywords:
- Lung Neoplasms
- Carcinoma, Non-Small Cell Lung
- Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
